Polycystic ovary syndrome (PCOS) is a common condition that affects women throughout their lives causing a range of symptoms and complications such as irregular or absent periods, difficulties getting pregnant, hormonal imbalances, obesity, diabetes, skin problems and abnormal patterns of hair growth. As most of these symptoms are common among women of reproductive age, PCOS may go undetected or misdiagnosed for years, meaning many women won’t have support to manage their symptoms which can affect their quality of life. The purpose of this study is to understand how PCOS patients are diagnosed and managed, their clinical outcomes, and the use of healthcare resources such as whether the diagnosis was made by a general practitioner or in a hospital setting, how long it took for a diagnosis to be made, the medications prescribed and costs to the United Kingdom (UK) National Health Service. We will also estimate the number of established and newly diagnosed patients, and the most common symptoms patients experience at diagnosis. Our study will allow us to better understand the diagnostic journey of patients with PCOS. The findings from this study may be used to point out gaps in the diagnosis of patients with this condition and consequently help to reduce the physical and financial burden experienced by women in the UK with this condition.
PCOS is a common endocrine disorder that is estimated to affect approximately 3-10% of women in the UK. PCOS is associated with a range of reproductive, metabolic, cardiovascular, and dermatologic symptoms including infertility, infrequent or absent menstrual periods, hirsutism (excessive hair growth), weight gain, and dermatological concerns. Given the heterogeneous nature of PCOS, and many of the symptoms being common among reproductive age women, a PCOS diagnosis is often delayed, involves multiple healthcare provider visits, or remains undiagnosed. The purpose of this study is to describe the diagnostic journey and management of patients with PCOS using UK CPRD linked to the England Hospital Episode Statistics (HES). We will conduct a retrospective cohort study of patients aged 15-49 years who have a confirmed or probable diagnosis of PCOS between January 1, 2003 and December 31, 2021. Data will be extracted from CPRD Aurum and linked to HES. The primary objectives of this study are to describe socio-demographic and clinical characteristics, describe the common symptoms at diagnosis, estimate the proportion of PCOS patients diagnosed by care setting and provider type, and describe the most common procedures used in the diagnosis of PCOS. Additionally, this study seeks to estimate the incidence and prevalence of PCOS in CPRD and to estimate the HCRU and costs in patients with a PCOS diagnosis. Patient demographics, clinical characteristics, diagnostic patterns, PCOS symptoms, and healthcare costs will be summarised using descriptive statistics. The findings from this study will allow us to better understand the diagnostic journey of patients with PCOS and subsequently may help to identify interventions or efficiencies that could reduce the physical and financial burden for women diagnosed with PCOS in the UK in the future.
The following outcomes will be measured and reported:
Baseline socio-demographic and clinical characteristics of patients included in the cohort;
- Common symptoms of PCOS;
- Time from symptoms onset until diagnosis;
- Proportion of PCOS patients diagnosed by care setting;
- Proportion of the types of healthcare professionals involved in diagnosis;
- Most common procedures used in the diagnosis of PCOS;
- Incidence and prevalence of PCOS in CPRD;
- HCRU of patients with PCOS;
- Cost to the NHS;
- Proportion of probable PCOS cases defined as the proportion of women with PCOS features and no diagnosis of PCOS; and
- Regional variations in the diagnostic pathways as well variations by deprivation status and ethnicity
Rana Maroun - Chief Investigator - Roche Diagnostics International Ltd
Rana Maroun - Corresponding Applicant - Roche Diagnostics International Ltd
Anne Connolly - Collaborator - NHS England
Johanna Sillman - Collaborator - Roche Diagnostics International Ltd
Joy Allen - Collaborator - Roche Diagnostics Ltd (UK)
Julia Eades - Collaborator - Roche Diagnostics International Ltd
Osvaldo Ulises Garay - Collaborator - Roche Diagnostics International Ltd
Ryan Walkley - Collaborator - Roche Diabetes Care, Inc
Scott Nelson - Collaborator - University of Glasgow
Sraboni Sarkar - Collaborator - Roche Diagnostics International Ltd
SUWEI WANG - Collaborator - Roche Molecular Systems, Inc
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;Patient Level Index of Multiple Deprivation